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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameMEDTRONIC SYNCHROMED INFUSION SYSTEM
Classification Namepump, infusion, implanted, programmable
Generic Nameimplanted infusion pump
ApplicantMEDTRONIC VASCULAR
PMA NumberP860004
Supplement NumberS038
Date Received05/28/1997
Decision Date09/18/1997
Product Code
LKK[ Registered Establishments with LKK ]
Advisory Committee General Hospital
Supplement Type Special Supplement
Supplement Reason labeling change - performance characteristics
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the inclusion of an add'l precaution regarding the complications associated with the development of an "inflammatory mass" at the tip of the implanted catheter to the synchromed infusion system techinical manual and the model 8703w indura intraspinal catheter technical manual.
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